A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma
- Conditions
- Relapsed and/or Refractory Multiple Myeloma
- Interventions
- Registration Number
- NCT06153251
- Lead Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Brief Summary
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
- Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease.
- Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry.
- Participants in Part A and Part B Cohort 1 must have received at least 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants must have adequate organ function.
- Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma.
- Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.
- Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis.
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Administration of BMS-986453 BMS-986453 - Administration of BMS-986453 Cyclophosphamide - Administration of BMS-986453 Fludarabine -
- Primary Outcome Measures
Name Time Method Number of participants with serious adverse events (SAEs) Up to 2 years Number of participants with treatment-emergent adverse events (AEs) Up to 2 years Number of participants with AEs leading to death Up to 2 years Number of participants with dose-limiting toxicities (DLTs) Up to 2 years Number of participants with AEs leading to discontinuation Up to 2 years
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Up to 2 years Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D)) Up to 2 years Progression-free survival (PFS) Up to 2 years Number of participants with very good partial response (VGPR) or better Up to 2 years Complete response rate (CRR) Up to 2 years Time to complete response (TTCR) Up to 2 years Persistence of BMS-986453 in peripheral blood Up to 2 years Defined as a transgene count greater than or equal to the lower limit of detection (LLOD)
Maximum observed concentration (Cmax) Up to 2 years Time of maximum observed concentration (Tmax) Up to 2 years Overall response rate (ORR) Up to 2 years Expansion rate Up to 2 years Defined as Cmax divided by Tmax
Time to response (TTR) Up to 2 years Duration of complete response (DOCR) Up to 2 years Duration of response (DOR) Up to 2 years
Trial Locations
- Locations (19)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights
🇺🇸San Francisco, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Local Institution - 0008
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Hôpital Saint-Louis
🇫🇷Paris, France
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitaetsklinikum Koeln
🇩🇪Köln, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
🇪🇸Salamanca, Spain